Who is sponsoring NCT01131689?

NCT01131689 is sponsored by Samsung Medical Center.

What condition does NCT01131689 study?

NCT01131689 studies Hepatocellular Carcinoma.

What drugs are being tested in NCT01131689?

Interventions: sorafenib, TS-1.

What is the status of NCT01131689?

NCT01131689 is currently COMPLETED.

Last reviewed 2012-01-31 · How we verify

Phase 1 Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma

NCT01131689 Phase 1 COMPLETED

In preclinical studies, 5-fluorouracil, one of the active metabolites of S-1, showed synergistic effect to sorafenib in human colon carcinoma cell lines. Therefore, sorafenib combined with S-1 might be more effective treatment for patients with advanced HCC than sorafenib monotherapy. The investigators propose to conduct a phase I study to determine maximal tolerated dose (MTD) of S-1 in combination with fixed dose of sorafenib in patients with advanced HCC

Details

Lead sponsor	Samsung Medical Center
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2009-09
Completion	2011-09

Conditions

Hepatocellular Carcinoma

Interventions

sorafenib, TS-1

Primary outcomes

MTD — 1 year
Primary objectives: 1\. To determine maximal tolerated dose (MTD) of S-1 combined with fixed dose of sorafenib 400mg twice daily. Secondary objectives: 1\. To evaluate toxicity profiles and dose-limiting toxicity (DLT)

Countries

South Korea